Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

NCT05773378 | Recruiting

• 1 other identifier: H-06-22-8219
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

More than one in five females experience the embarrassment and shame of urine leakage while exercising and this urinary incontinence (UI) is a substantial barrier to exercise. As many as one in three females with UI report that they limit their physical activity due to incontinence: 11.6% by not exercising at all, 11.3% by exercising less and 12.4% by changing the type of exercise they perform. It is imperative to look for alternatives to manage this condition, as it is a key reason why females abandon the very physical exercise that is necessary to maintain or improve their physical and mental health and their quality of life. While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations, no study has evaluated the impact of conservative interventions specifically on UI experienced predominantly during running.

Conditions

Urinary Incontinence

Keywords

exercise-induced urinary incontinence; running-induced urinary incontinence; intravaginal pessary; tampon; pelvic floor

Outcome Measures

Primary Outcomes (5)

• Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred

  At baseline, participants will be asked to complete a bladder diary, recording leakage experiences during each running session over a two-week period, while running without any intervention. This tracking will be repeated for another two-week period starting in the eighth week of running with the intervention (weeks 10-12 of the protocol). Participants will receive daily reminders to fill it out.

  at baseline, and during intervention week 10-12

• Patient's global impression of improvement

  Participants will be asked to rate their overall impression of symptom improvement over the 10-week intervention on a 7 step scale (7= very much worse, to 1= very much better). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their overall impression again at 16, 24 and 36 weeks.

  Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

• Patient's global satisfaction with treatment

  The participants will be asked how satisfied they were with their progress during the 10-weeks, on a scale from 0 to 100% (0 = not at all satisfied, 100 = completely satisfied). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their satisfaction again at 16, 24 and 36 weeks.

  Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

• International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)

  The ICIQ-FLUTS is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life in research and clinical practice, with validity, reliability and responsiveness established with rigour in several data sets. It has a total of 12 questions; four questions on filling symptoms, three on voiding symptoms and five questions on urinary incontinence symptoms. The overall score ranges from 0-48, where all subscales scores are added. Higher scores indicate greater impact of individual symptoms for the patient. Participants will be asked to complete it at baseline and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks.

  Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

  The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire that includes three questions about urinary incontinence frequency, severity, and impact on daily life, resulting in a score of 0-21. The fourth question aims to classify the type of urinary incontinence, for this study 'leaks when you are physically active/exercising.' The questionnaire has a Level A validation grade according to ICI standards, as its validity, reliability, and responsiveness have been tested in several data sets. Participants will be asked to complete it at baseline and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks.

  Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

Secondary Outcomes (10)

• Intervention questionnaire

  Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

• Adherence to each intervention

  Once a week during the 12 weeks of the study

• Unintended effects

  Once a week during the 12 weeks of the study

• Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score

  Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

• Changes in bladder neck height

  Baseline and post intervention (at 12 weeks)

Study Arms (3)

Pessary Intervention

EXPERIMENTAL

Participants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 10-week period. They will be instructed to use the pessary only while running and remove it and wash it with soap and water when the training is over. Uresta is a reusable and removable device made of hypoallergenic medical-grade resin that is inserted into the vagina to provide mechanical support. It comes with a starter kit with 3 different sizes which work for over 80% of women. Participants will be instructed on how to test the 3 sizes to find out which one is right for them.

Device: Pessary Intervention

Tampon Intervention

EXPERIMENTAL

Participants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period. The tampon should be used only while running and removed and discarded when the training is over. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.

Device: Tampon Intervention

Control Group

NO INTERVENTION

Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 10-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.

Interventions

Pessary Intervention DEVICE

Participants will receive a 3-size fitting kit and will fit the appropriate size based on manufacturer instruction. Once the size is verified, the participants will be asked to use the pessary while running over a 10-week period.

Pessary Intervention

Tampon Intervention DEVICE

Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.

Tampon Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 18 years and over who run at least twice a week for a minimum of 10K/week (minimum speed of 6 km/h to ensure high impact), who have done so for at least 6 months (to ensure adequate duration of exposure), and who commit to continue the same amount during the study period
• Who regularly (≥ 1 per week) experience urine leakage while running.

You may not qualify if:

• Any risk factors related to exercise;
• Pain or musculoskeletal injury at the time of the screening;
• History of urogenital surgery;
• Symptoms of the female athlete triad;
• Have a known neurologic disorder (e.g. stroke, multiple sclerosis);
• Pregnancy or partum within the previous year;
• For the in-lab assessment:
• Ability to run with a moderately full bladder for 38 minutes on a treadmill
• BMI ≥ 30
• Pelvic organ prolapse ≥ 2

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

McLean Function Measurement Lab

Ottawa, Ontario, K1S 1S2, Canada

RECRUITING

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MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Linda McLean

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda McLean

CONTACT

613-562-5800; lmclea2@uottawa.ca

Sabine Vesting

CONTACT

613-562-5800; svesting@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the School of Rehabilitation Sciences at University of Ottawa

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: March 17, 2023
• Study Start: April 14, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 10 years after the publication of the study results.
• Access Criteria: Planned use of data for systematic review or meta-analysis.

Locations

CA (1)